Using hymecromone to treat primary sclerosing cholangitis in adolescents and adults
A Study of Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis(HAAPS Study).
This study is testing if adding hymecromone to standard treatment can help adolescents and adults with primary sclerosing cholangitis feel better and improve their liver function.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 14 Years to 75 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 2 sites (Redwood City, California and 1 other locations) |
| Trial ID | NCT05295680 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of hymecromone combined with standard care for treating adolescents and adults diagnosed with primary sclerosing cholangitis (PSC). The primary objective is to compare the efficacy of this combination therapy against standard care alone. Secondary objectives include assessing changes in alkaline phosphatase levels and various biomarkers related to PSC over a six-month treatment period. Participants will be monitored for improvements in liver function and disease markers.
Who should consider this trial
Good fit: Ideal candidates are adolescents and adults diagnosed with primary sclerosing cholangitis confirmed by liver biopsy or imaging.
Not a fit: Patients currently receiving biologic therapies or with serious liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for managing primary sclerosing cholangitis, potentially improving patient outcomes.
How similar studies have performed: While there is limited data on hymecromone for PSC, similar studies exploring novel treatments for liver diseases have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of primary sclerosing cholangitis confirmed by liver biopsy and/or imaging study * If history of endoscopically confirmed inflammatory bowel disease, currently stable based on Mayo Score / Disease Activity Index (DAI) for Ulcerative Colitis Score ≤ 1, normal inflammatory markers (ESR, CRP and fecal calprotectin) and stable non-excluded medical therapy for at least 6 months Exclusion Criteria: * Currently receiving biologic therapies * Known allergy to hymecromone * Cholangiocarcinoma * Pregnancy * Serious liver disease
Where this trial is running
Redwood City, California and 1 other locations
- Stanford Clinic — Redwood City, California, United States (Recruiting)
- Stanford Clinic — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Aparna Goel, MD — Stanford University
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.